0000000000498189
AUTHOR
Tuomas Granlund
Continuous design control for machine learning in certified medical systems
AbstractContinuous software engineering has become commonplace in numerous fields. However, in regulating intensive sectors, where additional concerns need to be taken into account, it is often considered difficult to apply continuous development approaches, such as devops. In this paper, we present an approach for using pull requests as design controls, and apply this approach to machine learning in certified medical systems leveraging model cards, a novel technique developed to add explainability to machine learning systems, as a regulatory audit trail. The approach is demonstrated with an industrial system that we have used previously to show how medical systems can be developed in a con…
Medical Software Needs Calm Compliance
The promise of calm computing, a concept introduced by Mark Weiser more than 20 years ago, has been mostly realized today. For instance, as an end user, you expect to interact during your daily routine with a multitude of sophisticated services and applications without being aware of their technical implementation. All you need is a smartphone and an always-on Internet connection. peerReviewed